The Link Between BRCA Mutation and Endothelial Function - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- reactive hyperemia index will be assessed using the Endo-PAT2000
研究概览
简要总结
This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
- •Able and willing to sign an informed consent
排除标准
- •History of, or current, malignancy
- •History of:
- •Myocardial infarction
- •Ischemic or Hemorrhagic cerebrovascular conditions
- •Arterial embolic and thrombotic events
- •Ischemic heart disease
- •Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
- •Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)
研究组 & 干预措施
male BRCA mutations carriers
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Endothelial function assessment (Other)
male BRCA mutations carriers
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Cardiovascular biomarkers (Other)
male BRCA mutations carriers
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Endothelial cells (Other)
healthy males - control group
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Endothelial function assessment (Other)
healthy males - control group
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Cardiovascular biomarkers (Other)
healthy males - control group
Endothelial function assessment and Cardiovascular biomarkers
干预措施: Endothelial cells (Other)
结局指标
主要结局
reactive hyperemia index will be assessed using the Endo-PAT2000
时间窗: at baseline
will be assessed using the Endo-PAT2000
次要结局
- The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured(at baseline)
- Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.(at baseline)
- The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured(at baseline)
- The level of D-dimer - a cardiovascular risk biomarker will be measured(at baseline)
- Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.(at baseline)
- The level of C-reactive protein - a cardiovascular risk biomarker will be measured(at baseline)